Assessing Intellectual and Motor Outcomes in High-risk Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children, High-risk Infants. Basic parameters: 0 Days — 4 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy
Overview
Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP. In this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre/ University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.
Primary outcome measures
- A [Time frame: From near term to 4 months corrected gestational age]
- B [Time frame: Birth to 6 weeks]
- C [Time frame: 4 to 24 months]
Secondary outcome measures (3)
- A [Time frame: During the study period, ie. over five years]
- B [Time frame: 4 months]
- C [Time frame: 18 months]
Eligibility criteria
Inclusion Criteria (High Risk Group) :
- Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
- All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:
- All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight
- All encephalopathic infants
- Neurological risk factors (e.g., cerebral birth defect, injury/malformation on neuroimaging, persistently abnormal neurological exam)
(Control Group)
-A control arm will also be recruited.
Exclusion criteria
- Death prior to discharge from the neonatal unit (High-Risk Infants only)
- No parental consent (High-Risk and Control Infants)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Ireland · 4 centers
- Cork University Maternity Hospital — Cork
- INFANT Centre, University College Cork — Cork
- Coombe Women and Infant's Hospital — Dublin
- The Rotunda Hospital — Dublin
Identifiers
NCT: NCT06857539 · DM01